Analyzing Innovations Progress in the Gottlieb Era

Session Chair(s)

Nancy Bradish Myers, JD

President and Founder

Catalyst Healthcare Consulting, Inc, United States

FDA Commissioner Scott Gottlieb has advanced an ambitious plan to modernize drug development and FDA’s approach to regulation. He has taken bold new approaches to streamline clinical trials, engage in efficient, risk-based regulation, and advance innovation.

Gottlieb is focused on transformative innovations that hold the promise of both significantly impacting disease and reducing overall health care costs.

How is the agency’s approach impacting innovation? Is it making a difference? Are further changes needed? What does the future of drug development look like under Gottlieb? Where are the key opportunities for collaboration between FDA and industry?

This DIAmond Session will bring together top regulatory thought leaders from FDA, industry and the venture capital world, for an interactive, forward-looking discussion of FDA’s modernization plan and its impact on development of innovative therapies.

Learning Objective : Describe FDA’s Medical Innovation Development Plan; Identify implications for the future of drug development under Commissioner Gottlieb; Plan for impact of regulatory changes on drug development and business plans.

Kathy Hibbs

Panelist

Doug Cole, MD

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